Optimization of the Targeted Anticancer Therapies

NCT04484064 | Recruiting

• 2 other identifiers: CHUV-PCL-OpTAT-201565/15
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study includes an observational pharmacokinetic study and an interventional medication adherence study. The purpose of this study is 1) to describe the concentration-time profiles of targeted anticancer drugs and to characterize the concentration-effect/toxicity relationships in the target population of patients (observational study) and 2) to characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver modifiable adherence factors in patients participating in an adherence program (interventional study).

Conditions

Cancer

Keywords

Cancer; Medication adherence; Oral targeted anticancer drugs; Population pharmacokinetics; Pharmacodynamic-pharmacokinetics relationships

Outcome Measures

Primary Outcomes (3)

• Blood concentrations of targeted anticancer drugs

  During their medical visits, from 1 to 8 blood samples will be collected per patients at the same moment as routine blood sampling. Drug concentration will be measured by HPLC-MS/MS.

  A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).

• Apparition of adverse events of targeted anticancer drugs

  Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).

  Adverse events are monitored at each medical visit (once per month) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.

• Change from treatment start in efficacy of targeted anticancer drugs

  The progression free survival (PFS) is used to evaluate the drug efficacy. The PFS is defined as the time interval between the first dose of drug and the date of progression or any cause death. Patient without progression at the study end will be censored.

  The cancer progression is evaluated at each PET-scan (once per 3 months) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.

Secondary Outcomes (1)

• Medication adherence : persistence rate and daily implementation of targeted anticancer drugs

  12 months

Study Arms (2)

Standard care

NO INTERVENTION

Patients in the "standard care" arm will use an electronic adherence monitor (MEMS®) without any feedback (electronic data will be blinded to patients, clinicians and investigators until the analysis)

Adherence program

EXPERIMENTAL

Patients in the "adherence program" will use the MEMS® and the pharmacist will provide an electronic feedback on medication adherence since the last visit. The identified determinants of medication adherence will be discussed with the patient.

Behavioral: Adherence program

Interventions

Adherence program BEHAVIORAL

This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.

Adherence program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients to whom a targeted anticancer therapy is prescribed

You may not qualify if:

• Patients incapable of judgment or participants under tutelage

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: collaborator
• Krebsforschung Schweiz, Bern, Switzerland: collaborator

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (2)

• Bandiera C, Cardoso E, Locatelli I, Zaman K, Diciolla A, Digklia A, Stravodimou A, Cristina V, Aedo-Lopez V, Dolcan A, Sarivalasis A, Bouchaab H, Pasquier J, Dotta-Celio J, Peters S, Wagner D, Csajka C, Schneider MP. A pharmacist-led interprofessional medication adherence program improved adherence to oral anticancer therapies: The OpTAT randomized controlled trial. PLoS One. 2024 Jun 7;19(6):e0304573. doi: 10.1371/journal.pone.0304573. eCollection 2024.

  PMID: 38848380 DERIVED

• Bandiera C, Cardoso E, Locatelli I, Digklia A, Zaman K, Diciolla A, Cristina V, Stravodimou A, Veronica AL, Dolcan A, Sarivalasis A, Liapi A, Bouchaab H, Orcurto A, Dotta-Celio J, Peters S, Decosterd L, Widmer N, Wagner D, Csajka C, Schneider MP. Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data. JMIR Res Protoc. 2021 Jun 29;10(6):e30090. doi: 10.2196/30090.

  PMID: 34185020 DERIVED

MeSH Terms

Conditions

Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Chantal Csajka, PharmD, PhD

  Clinical Pharmacy Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Csajka, PharmD, PhD

CONTACT

21 314 42 63; chantal.csajka@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor of the Center for Research and Innovation in Clinical Pharmaceutical Sciences

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: July 23, 2020
• Study Start: May 1, 2015
• Primary Completion: December 1, 2020
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

CH (1)